Induction of LaborPhase 4NCT06990217
Comparing High Versus Low Dose of Oxytocin, in Gravida Women With BMI 30 and Above Which Are Undergoing Induction of Labor
A Phase 4 study testing Oxytocin Grindeks 10 IU/ml- solution for injection in people with Induction of Labor and Augmentation of Labor, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The goal of this clinical trial is to compare between higher and lower dose of oxytocin to induce delivery in obese women. Researches will compare between low and high doses of oxytocin. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Induction of Labor, Augmentation of Labor
- What is being tested?
- Oxytocin Grindeks 10 IU/ml- solution for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women at term (37-42 weeks), requiring the use of oxytocin for induction of labor or for augmentation of labor.
- BMI 30 and above
- Viable singleton pregnancies
- Cephalic presentation.
- No contraindication for vaginal delivery
Who cannot join
- Women with previous cesarean delivery
- Multiple pregnancy
- Multiple fetal malformations
- IUFD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Galit Garmi contact
About this study
Official title: Comparison of Oxytocin Dosing Regimen' Low Versus High, in Gravida Women With BMI 30 and Above Undergoing Induction of Labor
The goal of this clinical trial is to compare between higher and lower dose of oxytocin to induce delivery in obese women. Researches will compare between low and high doses of oxytocin. the study group will use high dose of oxytocin (20 units in 1000 ml) versus the control group which will use low dose of oxytocin (10 units of oxytocin in 1000 ml)
Read the detailed description
the duration and the progression of the first stage of labor is slower in obese women and oxytocin seems to be less effective in the treatment of protracted labor in obese women. There is no consensus in the literature about the optimal oxytocin dose. Hence, the objective of this study is to compare 2 oxytocin regimens, low VS high dose among obese women who need induction or augmentation of labor.
Women at term (37-42 weeks), requiring the use of oxytocin for induction of labor or for augmentation of labor. Who are obese (BMI 30 and above), Viable singleton pregnancies with Cephalic presentation. After their consent, will be randomization: in a 1:1 allocation.
Group 1 (control) will receive a low dose- 10 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.
Group 2 (study) will receive a high dose- 20 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.
The primary outcome of the study is the time from the start of oxytocin to delivery
Statistical analysis Mean time interval from initiation of augmentation/ induction with oxytocin until delivery was eight hours (±240 minutes), based on previous observation at the delivery ward. The aim of study is to demonstrate a difference of 2 hours between the 2 groups with an alpha of 0.05 and a power of 80%, a sample size of 64 women per group is required. The primary analysis will be performed on the groups as allocated, that is, by the intention to treat, including all women as randomized.
- Conditions
- Induction of Labor, Augmentation of Labor
- Being tested
- Oxytocin Grindeks 10 IU/ml- solution for injection
- Keywords
- induction of labor, augmentation of labor, obese, obese gravida, high dose of oxytocin in obese gravida
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin Grindeks 10 IU/ml- solution for injectionDrug
our study is aims to compare two oxytocin regimens - low VS high dose among obese women who need induction or augmentation of labor
| Study group | Role | What they receive |
|---|---|---|
| High dose oxytocin | Active comparator | This arm of the study will receive high dose oxytocin - 20 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h. Receives: Drug: Oxytocin Grindeks 10 IU/ml- solution for injection |
| Low dose oxytocin | Other | This arm of the study will receive low dose oxytocin- - 10 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h. Receives: Drug: Oxytocin Grindeks 10 IU/ml- solution for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from the start of oxytocin to delivery
our hypothesis that high dose of oxytocin shortens the time from the start of induction to delivery
Measured: from the start of induction till delivery
Secondary outcomes (14)
Maternal age
maternal age at enrollment
Measured: at enrollment
mode of delivery
Measured: at delivery
intrapartum fever
Measured: during labor
uterine rupture
Measured: up to 6 weeks after delivery
perineal tears
Measured: during delivery
PPH
Measured: up to 6 weeks
length of postpartum stay
normally a gravida's length of stay after normal delivery is 48 hours and after c-section is up to 3-4 days.
Measured: perinatal.
Maternal satisfaction
We will assess maternal satisfaction using a scale - Birth Satisfaction Scale-Revised (BSS-R). a five pont scale, 0 is totally disagree, 5 totally agree.
Measured: will be assessed up to 1 day after delivery
Neonatal outcomes
NICU admittion
Measured: up to 1 week
Neonatal outcomes
neonatal PH<7.1
Measured: up to 1 week
Apgar score
minimum 0 and maximum 10. zero is bad outcome 10 is good outcome
Measured: at 1, 5 and 10 minutes
GTPAL system
GTPAL system assessed by questionnaire
Measured: at enrollment
maternal weight
weight before pregnancy, weight at admission
Measured: at enrollment
maternal height
height
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the two study groups will get the same drug but different dosage.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rola Iskander, HaEmek Medical Center, Israel
- Investigators
- Rula Iskander, MD, Study chair, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990217
- Sponsor's protocol ID
- 0022-24-EMC
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: to protect patients privacy.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxytocin Dosing Regimen' Low Versus High, in Gravida Women With BMI 30 and Above Undergoing Induction of Labor
- ClinicalTrials.gov ID
- NCT06990217
- Acronym / sponsor ID
- 0022-24-EMC
- Conditions
- Induction of Labor, Augmentation of Labor
- Keywords
- induction of labor, augmentation of labor, obese, obese gravida, high dose of oxytocin in obese gravida
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare between higher and lower dose of oxytocin to induce delivery in obese women. Researches will compare between low and high doses of oxytocin. the study group will use high dose of oxytocin (20 units in 1000 ml) versus the control group which will use low dose of oxytocin (10 units of oxytocin in 1000 ml)
Detailed description
the duration and the progression of the first stage of labor is slower in obese women and oxytocin seems to be less effective in the treatment of protracted labor in obese women. There is no consensus in the literature about the optimal oxytocin dose. Hence, the objective of this study is to compare 2 oxytocin regimens, low VS high dose among obese women who need induction or augmentation of labor.
Women at term (37-42 weeks), requiring the use of oxytocin for induction of labor or for augmentation of labor. Who are obese (BMI 30 and above), Viable singleton pregnancies with Cephalic presentation. After their consent, will be randomization: in a 1:1 allocation.
Group 1 (control) will receive a low dose- 10 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.
Group 2 (study) will receive a high dose- 20 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h.
The primary outcome of the study is the time from the start of oxytocin to delivery
Statistical analysis Mean time interval from initiation of augmentation/ induction with oxytocin until delivery was eight hours (±240 minutes), based on previous observation at the delivery ward. The aim of study is to demonstrate a difference of 2 hours between the 2 groups with an alpha of 0.05 and a power of 80%, a sample size of 64 women per group is required. The primary analysis will be performed on the groups as allocated, that is, by the intention to treat, including all women as randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the two study groups will get the same drug but different dosage.
| Arm | Type | Receives |
|---|---|---|
| High dose oxytocin | Active comparator | Drug: Oxytocin Grindeks 10 IU/ml- solution for injectionThis arm of the study will receive high dose oxytocin - 20 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h. |
| Low dose oxytocin | Other | Drug: Oxytocin Grindeks 10 IU/ml- solution for injectionThis arm of the study will receive low dose oxytocin- - 10 units of oxytocin in 1000 ml STD. Starting rate 12 ml/h increase dose by 12 ml/h every 30 min up to 5 contractions / 10 min. Max dose 120 ml/h. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Women at term (37-42 weeks), requiring the use of oxytocin for induction of labor or for augmentation of labor.
- BMI 30 and above
- Viable singleton pregnancies
- Cephalic presentation.
- No contraindication for vaginal delivery
Key exclusion criteria (4 listed)
- Women with previous cesarean delivery
- Multiple pregnancy
- Multiple fetal malformations
- IUFD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin Grindeks 10 IU/ml- solution for injectionour study is aims to compare two oxytocin regimens - low VS high dose among obese women who need induction or augmentation of labor | Drug | High dose oxytocin, Low dose oxytocin |
Primary outcome
Time from the start of oxytocin to delivery
Time frame: from the start of induction till delivery
our hypothesis that high dose of oxytocin shortens the time from the start of induction to delivery
14 secondary outcomes
Maternal age
Time frame: at enrollment
mode of delivery
Time frame: at delivery
intrapartum fever
Time frame: during labor
uterine rupture
Time frame: up to 6 weeks after delivery
perineal tears
Time frame: during delivery
PPH
Time frame: up to 6 weeks
length of postpartum stay
Time frame: perinatal.
Maternal satisfaction
Time frame: will be assessed up to 1 day after delivery
Neonatal outcomes
Time frame: up to 1 week
Neonatal outcomes
Time frame: up to 1 week
Apgar score
Time frame: at 1, 5 and 10 minutes
GTPAL system
Time frame: at enrollment
maternal weight
Time frame: at enrollment
maternal height
Time frame: at enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No. to protect patients privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Galit Garmi contact
Rula Iskander, MD study chair
Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin Grindeks 10 IU/ml- solution for injection in people with Induction of Labor and Augmentation of Labor, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rula Iskander, MD (+972544357554, rula_isk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from the start of oxytocin to delivery (time frame: from the start of induction till delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.